Satapathy Bhabani Sankar, Pattnaik Gurudutta, Sahoo Rudra Narayan, Pattanaik Sovan, Sarangi Ashish K, Kandi Venkataramana, Mishra Snehasish, Rabaan Ali A, Mohanty Aroop, Sah Ranjit, Mohapatra Ranjan K
School of Pharmaceutical Sciences Siksha O Anusandhan Deemed to be University Bhubaneswar Odisha India.
School of Pharmaceutical Sciences Centurion University of Technology and Management Alluri Nagar Odisha India.
Health Sci Rep. 2023 Sep 3;6(9):e1540. doi: 10.1002/hsr2.1540. eCollection 2023 Sep.
Historically, a critical aetiological agent of health concern stays till eternity after its discovery, so shall it be with the COVID-19 outbreak. It has transformed human life to a 'new normal' with huge tolls on the social, psychological, intellectual and financial spheres.
This perspective aimed to collate numerous reported COVID-19 vaccine-associated adverse events and the predisposing factors. It focussed on the efficacy of mix-n-match (cocktail) vaccines to effectively counter COVID-19 infection to facilitate future research and possible interventions.
Databases like Scopus, Pubmed and the Web-of-science were searched for published literature on 'adverse events associated with COVID-19 vaccine'. The reports and updates from health agencies like the WHO and CDC were also considered for the purpose. The details with respect to the adverse events associated with COVID-19 vaccination and the predisposing factors were compiled to obtain insights and suggest possible future directions in vaccine research.
India stood strong to manage its health resources in time and turned into a dominant global vaccine supplier at a time when healthcare infrastructure of many countries was still significantly challenged. Developing indigenous vaccines and the vaccination drive in India were its major achievements during the second and the subsequent COVID-19 waves. The fully indigenous Covaxin vaccine, primarily as an emergency intervention, was successfully rapidly launched. Similar such vaccines for emergency use were developed elsewhere as well. However, all of these reached the marketplace with a 'emergency use only' tag, without formal clinical trials and other associated formalities to validate and verify them as these would require much longer incubation time before they are available for human use.
Many adverse events associated with either the first or the second/booster vaccination doses were reported. Evidently, these associated adverse events were considered as 'usually rare' or were often underreported. Without the additional financial or ethical burden on the vaccine companies, fortunately, the Phase IV (human) clinical trials of their manufactured vaccines are occurring by default as the human population receives these under the tag 'emergency use'. Thus, focused and collaborative strategies to unveil the molecular mechanisms in vaccine-related adverse events in a time-bound manner are suggested.
Reliable data particularly on the safety of children is lacking as majority of the current over-the-counter COVID-19 vaccines were for emergency use. Many of these were still in their Phase III and Phase IV trials. The need for a mutant-proof, next-gen COVID-19 vaccine in the face of vaccine-associated adverse events is opined.
从历史上看，一个引发健康问题的关键病因在被发现后会一直存在，新冠疫情爆发亦是如此。它已将人类生活转变为一种“新常态”，在社会、心理、智力和经济领域造成了巨大损失。
本观点旨在整理众多已报道的新冠疫苗相关不良事件及其诱发因素。重点关注混合搭配（鸡尾酒式）疫苗有效对抗新冠病毒感染的效果，以促进未来研究及可能的干预措施。
检索了Scopus、Pubmed和科学网等数据库中关于“新冠疫苗相关不良事件”的已发表文献。同时也考虑了世界卫生组织和美国疾病控制与预防中心等卫生机构的报告和更新内容。整理了与新冠疫苗接种相关不良事件及诱发因素的详细信息，以获取见解并为疫苗研究提出可能的未来方向。
在许多国家的医疗基础设施仍面临重大挑战之际，印度及时有力地管理其卫生资源，成为全球主要的疫苗供应国。研发本土疫苗以及在印度开展疫苗接种运动是该国在第二波及后续新冠疫情浪潮中的主要成就。完全本土研发的科维欣疫苗主要作为紧急干预措施，成功迅速推出。其他地方也研发了类似的紧急使用疫苗。然而，所有这些疫苗进入市场时都带有“仅紧急使用”标签，没有经过正式临床试验及其他相关手续来验证，因为这些需要更长的潜伏期才能供人类使用。
报告了许多与第一剂或第二剂/加强剂疫苗接种相关的不良事件。显然，这些相关不良事件被认为“通常罕见”或经常报告不足。幸运的是，由于人类在“紧急使用”标签下接种这些疫苗，疫苗生产公司在没有额外财务或伦理负担的情况下，其生产的疫苗默认进入了IV期（人体）临床试验。因此，建议采取有针对性的协作策略，及时揭示疫苗相关不良事件的分子机制。
由于目前大多数非处方新冠疫苗是用于紧急使用，缺乏特别是关于儿童安全性的可靠数据。其中许多仍处于III期和IV期试验阶段。鉴于疫苗相关不良事件，人们认为需要一种抗突变的下一代新冠疫苗。
